title: Efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a meta-analysis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH).
  
  
  METHODS
  A comprehensive search was done to identify randomized controlled trials comparing the efficacy and safety of tadalafil for LUTS/BPH with placebos. Meta-analytical techniques were applied to evaluate the differences in the study results.
  
  
  RESULTS
  Eight studies were identified and analyzed. Compared with placebo, tadalafil was associated with significant improvements in the International Prostate Symptom Score (IPSS) (mean difference = -2.19, p < 0.00001) and the International Index of Erectile Function (IIEF) score (mean difference = +4.66, p < 0.00001), despite the concomitant presence of erectile dysfunction. Significant differences were also observed in the IPSS irritative and obstructive subscores, IPSS quality of life index and BPH impact index. After pooling four doses (2.5, 5, 10 and 20 mg), tadalafil failed to produce a significant outcome in maximal urinary flow rate (Qmax) (mean difference = +0.26 ml/s, p = 0.14), but 5 mg of tadalafil significantly improved Qmax (mean difference = +0.63 ml/s, p = 0.04). No significant difference was detected in the incidence of serious adverse events (risk ratio = 1.00, p = 1.00) after tadalafil treatment.
  
  
  CONCLUSIONS
  Tadalafil showed good efficacy and safety for improving LUTS and erectile dysfunction in men with BPH, and 5 mg of tadalafil significantly improved Qmax.
authors.affiliation: School of Clinical Medicine, Southeast University, Nanjing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Dong
authors.forename: Lin
authors.initials: L
authors.lastname: Hao
authors.forename: Zhenduo
authors.initials: Z
authors.lastname: Shi
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.forename: Zhiguo
authors.initials: Z
authors.lastname: Zhang
authors.forename: Conghui
authors.initials: C
authors.lastname: Han
mesh_terms: D002243:Carbolines / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000188:drug therapy; D006801:Humans; D008297:Male; D061214:Patient Safety; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012306:Risk; D000068581:Tadalafil; D016896:Treatment Outcome; D014551:Urinary Tract / Q000187:drug effects*; D014570:Urologic Diseases / Q000188:drug therapy*; D064804:Urological Agents / Q000627:therapeutic use
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D064804:Urological Agents; D000068581:Tadalafil